<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20201212049687N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-29</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The home-based mirror therapy in reducing phantom pain in below knee  amputees</public_title>
      <acronym></acronym>
      <scientific_title>The effect of home-based mirror therapy in reducing phantom pain in below knee unilateral amputees</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58752</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization through envelopes prepared by a member of the research team and random numbers with the help of Randomaize.com will be printed and placed inside the envelope. The lid of the envelope will be closed and its contents will not be visible from the outside. Then, the purpose of the study is first explained to the person who meets the conditions, and the person, if desired, signs the informed consent form and takes an envelope, and then opens it and enters the intervention or control group based on the contents of the envelope, Blinding description: In this study, amputees in the first group will receive mirror therapy intervention and after the end of the tail group will receive conventional training without knowing the first group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Amputation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In this group, a mirror is prepared and placed in front of a healthy foot, and the amputated person tries to perform finger movements, bending, straightening of the wrist, and rotation of a healthy limb, and looks at healthy foot movements in a mirror. This is done daily for a while. It will be done for 14 minutes in a row for 6 weeks. The person is required to record the amount of pain reduction daily on a visual analogue scale. Intervention 2: Control group: In this group, the usual treatments, which include repeated and low strokes by the hand to the end and around the stump, and massage by the person throughout the stump. This will be done daily for 14 minutes for 6 weeks. The person is required to record the amount of pain reduction daily on a  visual analogue scale.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only part of the data such as information about the main outcome or the like can be shared.

When:
Access period starts from ۲۰۲۲

To whom:
The data of this study will be available only to researchers working in academic and scientific institutions

Conditions:
There is nothing wrong with using published content by mentioning the title in other articles

Where to obtain:
Applicants should refer to my email to receive the required documents or data.

How to obtain:
After the title of the study type, the applicant will email me and I will respond to their request by email if needed.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alirezataheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 332, Department of Orthotics and Prosthetics, Second Floor, School of Rehabilitation Sciences, University of Medical Sciences, Hezar Jerib St., Isfahan ,Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۶۱</zip>
        <telephone>+98 31 3792 5053</telephone>
        <email>taheri@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alirezataheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 332, Department of Orthotics and Prosthetics, Second Floor, School of Rehabilitation Sciences, University of Medical Sciences, Hezar Jerib St., Isfahan ,Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۶۱</zip>
        <telephone>+98 31 3792 5053</telephone>
        <email>taheri@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Traumatic amputation                                                                                                                                                                                                                                                     Unilateral amputation                                                                                                                                                                                                                                                                     Below knee amputation                                                                                                                                                                                                                                                         be over 18 years old                                                                                                                                                                                                                                                                              Have phantom limb pain greater than 3 on a numerical scale                                                                                 Be a man                                                                                                                                                                                                                                                                                                                                                                                                                                          A person must use a prosthesis                                                                                                                                                                                                                                                                                                 A maximum of 10 years have passed since the amputation                                                                                                Have phantom limb pain                                                                                                                                                                                                                                                                                                                             Have not used mirror therapy in the past</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Patients with stump abnormalities (patients with residual limb)                                            Patients with addiction                                                                                                                                                                                                                                                      Patients with brain injuries                                                                                                                                                                                                                                                      have special mental health problems                                                                                                                                                                                      Have vision problems                                                                                                                                                                                                                                                             Use of analgesics                                                                                                                                                                                                                                                                                  Use of sleeping pills                                                                                                                                                                                                                                                           Use of antidepressants</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In this group, a mirror is prepared and placed in front of a healthy foot, and the amputated person tries to perform finger movements, bending, straightening of the wrist, and rotation of a healthy limb, and looks at healthy foot movements in a mirror. This is done daily for a while. It will be done for 14 minutes in a row for 6 weeks. The person is required to record the amount of pain reduction daily on a visual analogue scale.</i_keyword>
      <i_keyword>Control group: In this group, the usual treatments, which include repeated and low strokes by the hand to the end and around the stump, and massage by the person throughout the stump. This will be done daily for 14 minutes for 6 weeks. The person is required to record the amount of pain reduction daily on a  visual analogue scale</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Phantom  pain score in Visual Analogue Scale(VAS). Timepoint: Measurement of  phantom pain at the beginning of the study (before the intervention) and 6 weeks after the start of mirror therapy training. Method of measurement: VAS questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-12</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Room 332, Department of Orthotics and Prosthetics, Second Floor, School of Rehabilitation Sciences, University of Medical Sciences, Hezar Jerib St., Isfahan ,Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
